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IL180898A0 - Sterile freezing, drying, storing, assaying and filling process (sfd-saf process) (pellet freeze-drying process for parenteral biopharmaceuticals - Google Patents

Sterile freezing, drying, storing, assaying and filling process (sfd-saf process) (pellet freeze-drying process for parenteral biopharmaceuticals

Info

Publication number
IL180898A0
IL180898A0 IL180898A IL18089807A IL180898A0 IL 180898 A0 IL180898 A0 IL 180898A0 IL 180898 A IL180898 A IL 180898A IL 18089807 A IL18089807 A IL 18089807A IL 180898 A0 IL180898 A0 IL 180898A0
Authority
IL
Israel
Prior art keywords
drying
sfd
assaying
storing
saf
Prior art date
Application number
IL180898A
Other versions
IL180898A (en
Original Assignee
Bayer Healthcare Llc
Bayer Technology Services Gmbh
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Bayer Healthcare Llc, Bayer Technology Services Gmbh filed Critical Bayer Healthcare Llc
Publication of IL180898A0 publication Critical patent/IL180898A0/en
Publication of IL180898A publication Critical patent/IL180898A/en

Links

Classifications

    • FMECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F26DRYING
    • F26BDRYING SOLID MATERIALS OR OBJECTS BY REMOVING LIQUID THEREFROM
    • F26B5/00Drying solid materials or objects by processes not involving the application of heat
    • F26B5/04Drying solid materials or objects by processes not involving the application of heat by evaporation or sublimation of moisture under reduced pressure, e.g. in a vacuum
    • F26B5/06Drying solid materials or objects by processes not involving the application of heat by evaporation or sublimation of moisture under reduced pressure, e.g. in a vacuum the process involving freezing
    • F26B5/065Drying solid materials or objects by processes not involving the application of heat by evaporation or sublimation of moisture under reduced pressure, e.g. in a vacuum the process involving freezing the product to be freeze-dried being sprayed, dispersed or pulverised
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1682Processes
    • A61K9/1694Processes resulting in granules or microspheres of the matrix type containing more than 5% of excipient

Landscapes

  • Engineering & Computer Science (AREA)
  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Molecular Biology (AREA)
  • Mechanical Engineering (AREA)
  • General Engineering & Computer Science (AREA)
  • Drying Of Solid Materials (AREA)
  • Sampling And Sample Adjustment (AREA)
  • Investigating Or Analysing Biological Materials (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Agricultural Chemicals And Associated Chemicals (AREA)

Abstract

Process for producing containers of a freeze-dried product wherein droplets of the product are frozen to form pellets, the pellets are freeze-dried, assayed and loaded into the containers.
IL180898A 2004-07-23 2007-01-23 Sterile freezing, drying, storing, assaying and filling process (sfd-saf process) (pellet freeze-drying process for parenteral biopharmaceuticals) IL180898A (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US59088104P 2004-07-23 2004-07-23
PCT/EP2005/007455 WO2006008006A1 (en) 2004-07-23 2005-07-09 Sterile freezing, drying, storing, assaying and filling process (sfd-saf process) (pellet freeze-drying process for parenteral biopharmaceuticals)

Publications (2)

Publication Number Publication Date
IL180898A0 true IL180898A0 (en) 2007-07-04
IL180898A IL180898A (en) 2011-10-31

Family

ID=35426977

Family Applications (1)

Application Number Title Priority Date Filing Date
IL180898A IL180898A (en) 2004-07-23 2007-01-23 Sterile freezing, drying, storing, assaying and filling process (sfd-saf process) (pellet freeze-drying process for parenteral biopharmaceuticals)

Country Status (9)

Country Link
US (1) US7836606B2 (en)
EP (1) EP1794524B1 (en)
JP (1) JP4829229B2 (en)
AT (1) ATE542095T1 (en)
AU (1) AU2005263465B2 (en)
CA (1) CA2574614C (en)
DK (1) DK1794524T3 (en)
IL (1) IL180898A (en)
WO (1) WO2006008006A1 (en)

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RU2578010C1 (en) * 2014-11-13 2016-03-20 Федеральное государственное бюджетное научное учреждение "Всероссийский научно-исследовательский институт механизации животноводства" (ФГБНУ ВНИИМЖ) Vacuum-sublimation dryer
BR112017025819B1 (en) 2015-06-01 2022-03-15 Ima Life North America Inc Freeze drying system for bulk product, method for lyophilizing a product and method for lyophilizing bulk product containing liquid
US10605527B2 (en) * 2015-09-22 2020-03-31 Millrock Technology, Inc. Apparatus and method for developing freeze drying protocols using small batches of product
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Also Published As

Publication number Publication date
WO2006008006A1 (en) 2006-01-26
JP2008507307A (en) 2008-03-13
DK1794524T3 (en) 2012-04-16
CA2574614A1 (en) 2006-01-26
AU2005263465B2 (en) 2010-07-29
JP4829229B2 (en) 2011-12-07
US20080060213A1 (en) 2008-03-13
IL180898A (en) 2011-10-31
AU2005263465A1 (en) 2006-01-26
ATE542095T1 (en) 2012-02-15
US7836606B2 (en) 2010-11-23
EP1794524B1 (en) 2012-01-18
CA2574614C (en) 2013-12-03
EP1794524A1 (en) 2007-06-13

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